With immediate effect, these types of medical software included in the management of Class II and Class III medical devices!

On July 8,China NMPA officially issued the “Guiding Principles for the Classification and Definition of AI  Medical Software Products”(hereinafter referred to as the “Guiding Principles”).

The guiding principles show that the AI  medical software in this principle refers to independent software that uses AI  technology to achieve its medical purposes based on medical device data.

The processing object of the software product is medical device data, and its core function is the processing, measurement, model calculation and analysis of medical device data, and it is used for medical purposes, which is in line with the definition of medical device in the regulations on the supervision and administration of medical devices, and within the scope of medical device management.

The specific management category should be determined in combination with the expected use of the product, algorithm maturity and other factors. For the AI  medical software with low algorithm maturity in medical application, if it is used to assist decision-making, such as providing clinical diagnosis and treatment suggestions in  lesion feature recognition, lesion nature determination, medication guidance and treatment plan making, it should be managed according to the Class Ⅲ medical devices; If it is used for non auxiliary decision-making, such as data processing and measurement to provide clinical reference information, it should be managed according to the  Class Ⅱ medical devices.

For the AI medical software with high algorithm maturity in medical application (the safety and effectiveness have been fully confirmed), its management category is implemented according to the current “Medical Device Classification Directory “and classification definition file (as shown in the figure below).

As of the date of this circular, AI medical software products shall apply for registration in accordance with the above principles.The products that have been approved to be registered as medical devices shall continue to be reviewed and approved in accordance with the categories originally accepted.

For AI medical software products that have been approved to be registered as medical devices, their registration certificates will continue to be valid during the validity period.If the registration application is filed within the validity period of the registration certificate, or the registration certificate expires during the product category conversion period, the registrant can apply to the original examination and approval department for the extension of the original registration certificate.

According to the statistics of Zhongcheng medical equipment, by the end of 2020, 591 manufacturing enterprises with medical software product registration certificate have been established in China. Among them, the number of newly established medical software manufacturers increased from 26 in 2013 to 37 in 2017.

From the point of product registration, in recent years, the number of medical software registration in China has been increasing year by year.By the end of 2020, the total number of effective medical software registration products in China has increased from 161 in 2016 to 716 in 2020, with a compound growth rate of 45.2%. Among them, the number of medical software registration in 2020 has increased by 30.7% compared with that in 2019.

According to the comparison of medical software management categories, among the registered software products, there are 682 Class II products, accounting for 95% of 34 cases of Class III products, accounting for 5% of the total.

From the perspective of subdivision, by the end of 2020, there have been a total of 1123 medical software registration licenses in China, among which 730 are valid. The distribution of each category is as follows:33 pieces of treatment planning software, 441 pieces of image processing software, 165 pieces of data processing software, 15 pieces of decision support software, 72 pieces of in vitro diagnostic software and 4 pieces of other software.

For an Enlishi copy of the  “Guiding Principles”，please email  info@inspirativemed.com